JEDENTAL PSROFILL SELF-CURE COMPOSITE

Material, Tooth Shade, Resin

JEDENTAL CO., INC.

The following data is part of a premarket notification filed by Jedental Co., Inc. with the FDA for Jedental Psrofill Self-cure Composite.

Pre-market Notification Details

Device IDK933656
510k NumberK933656
Device Name:JEDENTAL PSROFILL SELF-CURE COMPOSITE
ClassificationMaterial, Tooth Shade, Resin
Applicant JEDENTAL CO., INC. 324 SECOND ST. PIKE Southampton,  PA  18966
ContactJohn Wong
CorrespondentJohn Wong
JEDENTAL CO., INC. 324 SECOND ST. PIKE Southampton,  PA  18966
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-27
Decision Date1993-11-17

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